Model Number 3389-40 |
Device Problems
Break (1069); Difficult to Remove (1528); Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received by a manufacture representative (rep) via a health care professional (hcp) regarding an implantable neurostimulator (ins).It was reported the event occurred during the procedure.Upon opening the lead kit for lead insertion the white spacer collar was missing from the kit.During the lead insertion for deep brain stimulation (dbs) (parkinson's disease) the peel away component of the guide wire was being removed to facilitate the guidewire removal from the inserted lead on the micro targeting system.The white peel away bridge and guide wire sheared off leaving the guidewire intact with the lead.A new lead was open and inserted with no subsequent issues in removing the guide wire.No environmental/external/patient factors were thought to have led or contributed to the issue.No troubleshooting/actions/interventions were performed.The issue was resolved at the time of the report.
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Manufacturer Narrative
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Continuation of concomitant products: product id neu_stylet_acc, lot# unknown, product type: accessory.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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On 2019-aug-08 reporter occupation: (for, rep, hcp): additional information was received.There was reportedly no user error related to the event.
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Manufacturer Narrative
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Concomitant medical products: the main component of the system and other applicable components are: product id: neu_stylet_acc: product type: accessory.Analysis of the lead (lot number:) revealed a packaging part was missing from the kit.Analysis of the stylet (serial/lot number: unknown) revealed the handle and wire were broken.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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